MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; NRY

Model Number PAPS3-A

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra engine canister (canister), aspiration tubing (tubing), a penumbra engine (engine), a penumbra system ace 60 reperfusion catheter (ace60), and a non-penumbra stent retriever.During the procedure, the tubing was connected to the patient and aspiration was initiated.However, none of the engine indicator lights were illuminated.The physician reset the engine but the issue was not resolved.Next, the physician decided to remove the canister and exchange it for a new one.It was also reported that the lid of the canister felt loose.The procedure was then completed using the new canister, the same engine, the same tubing, the same ace60, and the same stent retriever.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the canister was undamaged.Conclusions: evaluation of the returned canister could not confirm the reported complaint.During functional testing, the canister was seated onto a demonstration engine and the engine was able to achieve vacuum pressure within specification and all four vacuum indicator lights illuminated.Penumbra pump canisters are 100% visually inspected and functionally tested during in-process inspection by the supplier.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10451953
• MDR Text Key: 204389360
• Report Number: 3005168196-2020-01283
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548010007
• UDI-Public: 00814548010007
• Combination Product (y/n): Y
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PAPS3-A
• Device Catalogue Number: PAPS3
• Device Lot Number: S11613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1